Insulin Infusion Diabetes Ulcer

NCT00700154 | Terminated DMC

• 1 other identifier: IICVS_00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Normoglycemia is important for the outcome of surgical and medical conditions. Insulin infusions have been studied to achieve normoglycemia during these circumstances and have proved to be useful. Insulin given by subcutaneous injections has longer duration compared to intravenous given insulin which makes it more difficult to control. The hypothesis behind the trial is the concept that insulin infusion is more effective in reaching normoglycemia in diabetic subjects during treatment for ulcer infections and/or planned cardio-vascular surgery.

• The study evaluates a target controlled insulin infusion or conventional therapy as antidiabetic treatment during ulcer infection and after cardio- vascular surgery.
• Secondary efficacy parameter will be hospital stay, laboratories for inflammation and oxidative stress.

Conditions

Diabetes Mellitus; Insulin Resistance; Hyperglycemia; Surgery; Ulcers; Infection

Keywords

Vascular Surgery; Complications; Hyperglycemia; Insulin infusion; Diabetic ulcers; Infection

Outcome Measures

Primary Outcomes (1)

• Plasma glucose levels

  4 weeks

Secondary Outcomes (3)

• Hospital stay

  4 weeks

• HbA1c

  4 weeks

• laboratories for inflammation and oxidative stress

  4 weeks

Study Arms (2)

Insulin infusion (aspart)

EXPERIMENTAL

Procedure: Insulin infusion

Standard care

NO INTERVENTION

Glucose control according to standard care at the ward, i.e., sliding scale insulin at the discretion of responsible physician.

Interventions

Insulin infusion PROCEDURE

The infusion, a fast acting insulin analog in 1 Unit/ml of NaCl, starts prior the surgery the operation day for all patients and stops during the postoperative care in the control group (conventional therapy), the intervention group continues for three full days with insulin infusion. After the transition day (the fourth day) multiple doses of mixinsulin continues until the study ends 4 weeks after the randomization.

Also known as: Insulin aspart: NovoRapid

Insulin infusion (aspart)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diabetes type 1 or type 2.
• Older than 18 years.
• Patients scheduled for cardio- vascular surgery and/ or acute ulcer infection.
• Hyperglycaemia: Capillary P-glucose above 8 mmol/L.
• Informed consent obtained.

You may not qualify if:

• Patients having any of the following at randomization will not be included in the study:
• Unconsciousness: not possible to wake up.
• Ketoacidosis: pH less or equal to 7.30.
• Hyperosmolar syndrome: S-Na more or equal to 150 mmol/L.
• Kidney failure: calculated GFR \< 30 mL/min.
• Pregnancy.
• Mental condition making the subject unable to understand the concepts and risk of the study

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Department of Vascular Surgery, Karolinska University Hospital

Stockholm, SE-171 76, Sweden

Location

Related Publications (23)

• Malmstedt J, Wahlberg E, Jorneskog G, Swedenborg J. Influence of perioperative blood glucose levels on outcome after infrainguinal bypass surgery in patients with diabetes. Br J Surg. 2006 Nov;93(11):1360-7. doi: 10.1002/bjs.5466.

  PMID: 16779879 BACKGROUND

• Bonnier M, Lonnroth P, Gudbjornsdottir S, Attvall S, Jansson PA. Validation of a glucose-insulin-potassium infusion algorithm in hospitalized diabetic patients. J Intern Med. 2003 Feb;253(2):189-93. doi: 10.1046/j.1365-2796.2003.01085.x.

  PMID: 12542559 BACKGROUND

• Van den Berghe G, Wilmer A, Milants I, Wouters PJ, Bouckaert B, Bruyninckx F, Bouillon R, Schetz M. Intensive insulin therapy in mixed medical/surgical intensive care units: benefit versus harm. Diabetes. 2006 Nov;55(11):3151-9. doi: 10.2337/db06-0855.

  PMID: 17065355 BACKGROUND

• Bastard JP, Maachi M, Lagathu C, Kim MJ, Caron M, Vidal H, Capeau J, Feve B. Recent advances in the relationship between obesity, inflammation, and insulin resistance. Eur Cytokine Netw. 2006 Mar;17(1):4-12.

  PMID: 16613757 BACKGROUND

• Brismar K, Fernqvist-Forbes E, Wahren J, Hall K. Effect of insulin on the hepatic production of insulin-like growth factor-binding protein-1 (IGFBP-1), IGFBP-3, and IGF-I in insulin-dependent diabetes. J Clin Endocrinol Metab. 1994 Sep;79(3):872-8. doi: 10.1210/jcem.79.3.7521354.

  PMID: 7521354 BACKGROUND

• Hadi HA, Suwaidi JA. Endothelial dysfunction in diabetes mellitus. Vasc Health Risk Manag. 2007;3(6):853-76.

  PMID: 18200806 BACKGROUND

• Abourizk NN, Vora CK, Verma PK. Inpatient diabetology. The new frontier. J Gen Intern Med. 2004 May;19(5 Pt 1):466-71. doi: 10.1111/j.1525-1497.2004.30133.x.

  PMID: 15109346 BACKGROUND

• Collier B, Dossett LA, May AK, Diaz JJ. Glucose control and the inflammatory response. Nutr Clin Pract. 2008 Feb;23(1):3-15. doi: 10.1177/011542650802300103.

  PMID: 18203960 BACKGROUND

• Griesdale DE, de Souza RJ, van Dam RM, Heyland DK, Cook DJ, Malhotra A, Dhaliwal R, Henderson WR, Chittock DR, Finfer S, Talmor D. Intensive insulin therapy and mortality among critically ill patients: a meta-analysis including NICE-SUGAR study data. CMAJ. 2009 Apr 14;180(8):821-7. doi: 10.1503/cmaj.090206. Epub 2009 Mar 24.

  PMID: 19318387 BACKGROUND

• Sjoholm A, Nystrom T. Inflammation and the etiology of type 2 diabetes. Diabetes Metab Res Rev. 2006 Jan-Feb;22(1):4-10. doi: 10.1002/dmrr.568.

  PMID: 15991254 BACKGROUND

• Sjoholm A, Nystrom T. Endothelial inflammation in insulin resistance. Lancet. 2005 Feb 12-18;365(9459):610-2. doi: 10.1016/S0140-6736(05)17912-4.

  PMID: 15708106 BACKGROUND

• Campbell RK. Etiology and effect on outcomes of hyperglycemia in hospitalized patients. Am J Health Syst Pharm. 2007 May 15;64(10 Suppl 6):S4-8. doi: 10.2146/ajhp070100.

  PMID: 17494892 BACKGROUND

• Van den Berghe G, Schetz M, Vlasselaers D, Hermans G, Wilmer A, Bouillon R, Mesotten D. Clinical review: Intensive insulin therapy in critically ill patients: NICE-SUGAR or Leuven blood glucose target? J Clin Endocrinol Metab. 2009 Sep;94(9):3163-70. doi: 10.1210/jc.2009-0663. Epub 2009 Jun 16.

  PMID: 19531590 BACKGROUND

• Kotronen A, Lewitt M, Hall K, Brismar K, Yki-Jarvinen H. Insulin-like growth factor binding protein 1 as a novel specific marker of hepatic insulin sensitivity. J Clin Endocrinol Metab. 2008 Dec;93(12):4867-72. doi: 10.1210/jc.2008-1245. Epub 2008 Sep 16.

  PMID: 18796514 BACKGROUND

• King GL. The role of inflammatory cytokines in diabetes and its complications. J Periodontol. 2008 Aug;79(8 Suppl):1527-34. doi: 10.1902/jop.2008.080246.

  PMID: 18673007 BACKGROUND

• Pickup JC. Inflammation and activated innate immunity in the pathogenesis of type 2 diabetes. Diabetes Care. 2004 Mar;27(3):813-23. doi: 10.2337/diacare.27.3.813.

  PMID: 14988310 BACKGROUND

• Haynes WG. Role of leptin in obesity-related hypertension. Exp Physiol. 2005 Sep;90(5):683-8. doi: 10.1113/expphysiol.2005.031237. Epub 2005 Aug 16.

  PMID: 16105937 BACKGROUND

• Gomes F, Telo DF, Souza HP, Nicolau JC, Halpern A, Serrano CV Jr. Obesity and coronary artery disease: role of vascular inflammation. Arq Bras Cardiol. 2010 Feb;94(2):255-61, 273-9, 260-6. doi: 10.1590/s0066-782x2010000200021. English, Portuguese, Spanish.

  PMID: 20428625 BACKGROUND

• Arai Y, Kojima T, Takayama M, Hirose N. The metabolic syndrome, IGF-1, and insulin action. Mol Cell Endocrinol. 2009 Feb 5;299(1):124-8. doi: 10.1016/j.mce.2008.07.002. Epub 2008 Jul 11.

  PMID: 18672019 BACKGROUND

• Galic S, Oakhill JS, Steinberg GR. Adipose tissue as an endocrine organ. Mol Cell Endocrinol. 2010 Mar 25;316(2):129-39. doi: 10.1016/j.mce.2009.08.018. Epub 2009 Aug 31.

  PMID: 19723556 BACKGROUND

• Subramaniam B, Panzica PJ, Novack V, Mahmood F, Matyal R, Mitchell JD, Sundar E, Bose R, Pomposelli F, Kersten JR, Talmor DS. Continuous perioperative insulin infusion decreases major cardiovascular events in patients undergoing vascular surgery: a prospective, randomized trial. Anesthesiology. 2009 May;110(5):970-7. doi: 10.1097/ALN.0b013e3181a1005b.

  PMID: 19387173 BACKGROUND

• Van den Berghe G. Endocrine evaluation of patients with critical illness. Endocrinol Metab Clin North Am. 2003 Jun;32(2):385-410. doi: 10.1016/s0889-8529(03)00005-7.

  PMID: 12800538 BACKGROUND

• Scurlock C, Raikhelkar J, Mechanick JI. Critique of normoglycemia in intensive care evaluation: survival using glucose algorithm regulation (NICE-SUGAR)--a review of recent literature. Curr Opin Clin Nutr Metab Care. 2010 Mar;13(2):211-4. doi: 10.1097/MCO.0b013e32833571f4.

  PMID: 20010098 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance; Hyperglycemia; Ulcer; Infections

Interventions

Insulin Infusion Systems; Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Delivery Systems; Drug Therapy; Therapeutics; Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment; Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Kerstin Brismar, Professor

  Karolinska Institutet

  STUDY DIRECTOR

• Mats Bonnier, M.D

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 9, 2008
• First Posted: June 18, 2008
• Study Start: November 1, 2011
• Primary Completion: December 21, 2020
• Study Completion: December 21, 2020
• Last Updated: December 23, 2020

Record last verified: 2020-12

Locations

SE (1)